NCT03681223 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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Salamon CG, Lewis C, Priestley J, Gurshumov E, Culligan PJ
Prospective study of an ultra-lightweight polypropylene Y mesh for robotic sacrocolpopexy. Int Urogynecol J. 2013 Aug;24(8):1371-5. doi: 10.1007/s00192-012-2021-7. Epub 2013 Jan 8.
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Surgical treatment of vaginal apex prolapse. Obstet Gynecol. 2013 Feb;121(2 Pt 1):354-374. doi: 10.1097/AOG.0b013e31827f415c.

A Prospective Randomized Trial Comparing Restorelle® Y Mesh vs. Vertessa® Lite Y Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy

Details for clinical trial NCT03681223

Clinical trial NCT03681223 - References